UMIN-CTR Clinical Trial

Public title

A multicenter randomized controlled trial of new-generation microwave ablation and radiofrequency ablation for hepatocellular carcinoma

Acronym

A multicenter RCT of new-generation MWA and RFA for HCC

Scientific Title

A multicenter randomized controlled trial of new-generation microwave ablation and radiofrequency ablation for hepatocellular carcinoma

Scientific Title:Acronym

A multicenter RCT of new-generation MWA and RFA for HCC

Region

Japan

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To compare the safety and the efficacy of new-generation microwave ablation and radiofrequency ablation for hepatocellular carcinoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

The primary endpoint is the technical success rate evaluated by the CT scan taken after the first session of new-generation microwave ablation or radiofrequency ablation
The secondary endpoints are 1) complete ablation ratio of tumors after the final session of of new-generation microwave ablation or radiofrequency ablation, 2) the number of sessions until completion of the treatment, and adverse event ratio.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

radiofrequency ablation

Interventions/Control_2

new-generation microwave ablation

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

100

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Patient at the age of 20 to 100 when the informed consent was obtained
2. Patient with histopathologically confirmed carcinoma or tumors showing characteristic imaging features of hepatocellular carcinoma
3. Tumors were unresectable or patient declined surgery
4. Three or fewer tumors, each 3 cm or less in diameter, or a solitary lesion, 5 cm or less in diameter (Patients with both primary and recurrent tumors were included. Patients with local tumor progression were excluded)
5. No extrahepatic metastasis or vascular invasion
6. Patient with written informed consent

Key exclusion criteria

1. Patient with prothrombin activity of 50% or less. Patient with low platelet count that cannot be corrected by lusutrombopag or platelet transfusion
2. Patient with refractory ascites and at high risk of peritoneal bleeding
3. Patient with enterobiliary reflux
4. Contrast-enhanced CT cannot be performed because of renal dysfunction (creatinine of 2 mg/dL or more) or allergic adverse reactions to iodine contrast agents
5. Child-Pugh class C
6. ASA's (American Society of Anesthesiologists) physical score 3 or above
7. Patient who cannot accept necessary treatments, such as blood transfusion, because of religious reasons and others
8. Patient who cannot follow medical instructions because of dementia and others
9. Patient with tumors not visualized by ultrasonography or not accessible
10. Patient with adhesion between tumors and the gastrointestinal tract which may cause GI tract penetration or perforation
11.Patient with tumors adjacent to the major Glisson's capsule which may cause serious biliary injury or hepatic infarction
12.Patient not considered eligible to participate in this study by the attending doctor due to various reasons

Target sample size

210

Name of lead principal investigator

1st name
Middle name
Last name	SHUICHIRO SHIINA

Organization

Juntendo University

Division name

Department of Gastroenterology

Zip code

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

ivo@juntendo.ac.jp

Name of contact person

1st name
Middle name
Last name	SHUICHIRO SHIINA

Organization

Juntendo University

Division name

Department of Gastroenterology

Zip code

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL

Email

ivo@juntendo.ac.jp

Institute

Juntendo University

Institute

Department

Personal name

Organization

Juntendo University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

順天堂大学大学院医学部附属順天堂医院

Date of disclosure of the study information

2019

Year

01

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2018

Year

09

Month

26

Day

Date of IRB

Anticipated trial start date

2018

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

01

Month

04

Day

Last modified on

2019

Year

02

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039468